Visinge Consulting has supported Utbildningsfonden for many years to improve and build schools in inaccessible areas of Liberia. We will continue to do that in 2019 also! More information about this […]
Your partner in Process Development and Regulatory Compliance
Both knowledge and experience are necessary to implement a process as described, understood and maintained over time. Visinge delivers that from idea to implemented process.
Visinge has long experience in the regulated industry providing services to pharmaceutical companies, medical device companies and to the pharmacy business. We usually work with improvements to better fullfil regulatory requirements, to make processes more efficient or to actually do the validation and qualification work.
There are ways of working and sometimes the processes are described. The processes define how to manage products or services through the company. But do they support the overall objectives of the company? Do they meet internal and external requirements? Are they efficient enough to keep up speed and while still maintaining quality? We have great experience in describing a process, identifying waste and outlining improvements going forward.
Visinge has worked a lot with IT-related processes both from a supplier prospective and also from a customer or user perspective. From infrastructure to systems and applications, we have been an active part implementing ITIL processes in a pharmaceutical company. We have also been an active part in outsourcing contracts. Cloud services need extra attention in the contractual and operational work.
Visinge just finished a project to validate a cloud based application (Software-as-a-Service) for a Swedish medical device company. The validation covered regulatory requirement (EU and US) for medical device.
Visinge delivered validation of a Learning Management System (LMS), delivered as a cloud solution (Software-As-A-Service (SaaS)), into a GxP environment. The validation ensure the business process and system fulfills regulatory requirements, […]